This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a Manager – SSU you will be required to coordinate, manage and facilitate the activities related to preparation, review and approval of country related and site level submissions in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards; and to ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment
Overview of the role
- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People,Clients and Performance.
- As a Manager, the employee is expected to recognize the importance of and create a culture ofprocess improvement with a focus on streamlining our processes adding value to our business andmeeting client needs.
- Travel (approximately 25%) domestic and/or international.
- Leadership: Sets a clear and convincing future direction, while communicating with clarity.
- Teamwork: Builds strong and effective teams, valuing different contributions; works with and throughothers, involving people in issues that affect them.
- Energizing &Developing Others: Creates an environment that motivates people; Identifiesdevelopment opportunities for self and others; Acts as a coach and mentor and shares expertise.
- Delivery to Customers: Delivers high quality standards and strives for excellence; Acts in a proactive,flexible and responsive manner to customer needs.
- Building Relationships: Establishes good relationships internally and externally.
- Personal Effectiveness: Operates independently with a willingness to make decisions; Projects credibility and makes a professional and positive impression on others; Monitors progress and holdself and others accountable.
- Commercial Awareness: Understand the ICON business globally; Controls costs and thinks in terms of profit, loss and added value; Promotes ICON effectively in all interactions.
- Robust Thinking: Identifies the key elements of a situation and any gaps and inconsistencies in data.Makes rational judgements from available information and analysis.
- Observe the regulatory and EC/IRB environments and ensure the maintenance of an up-to-datedatabase on EC and regulatory requirements.
- Serve as Global Lead, as necessary.
- Proactively identify and implement process improvement initiatives as appropriate
- Liaise with other managers within Clinical Operations to improve the effectiveness of the organization.
- Liaise with colleagues from all other departments to improve the effectiveness of the organization.
- Participate in business development activities and client meetings by assisting in the preparation andpresentation of Clinical Operations information in Bid Defense meetings, Kick-Off meetings and business proposals.
- Maintain confidentiality of management and personnel information, as appropriate.
- Represent Clinical Operations in sponsor and internal audits.
- Perform tasks and duties as assigned by Senior Management.
Supervision
- Review study performance in each country within their remit and as applicable in each region, and instigate actions to improve performance.
- Review study performance for every study led by a study authorization Lead from a country withintheir remit, and instigate actions to improve performance.
- Ensure team compliance with ICON systems and procedures.
- Ensure that study authorization activities are in alignment with department metrics and goals.
- Where necessary, support team in study start up related issues within his/her country/region.
- Oversee management of submissions (start-up and ongoing) and study start-up activities (applicable) to ensure they are conducted in an effective manner, meeting sponsor timelines,contractual requirements and expectations; and in adherence with ICON SOPs and appropriateregulations.
- Oversee management of studies in regards to Department goals set regarding quality, timelines andmetrics.
- Provide financial oversight to ensure appropriate profitability.
- Monitor and manage staff workload to optimize resource utilization.
- Effectively manage staff through open and timely sharing of information, regular performance reviewand feedback, and setting of clear goals and objectives. Ensure individual and team achievementsare appropriately recognized.
- Provide mentoring and training to staff ensuring that all necessary training is provided according tojob title; act as a role model to team members.
- Continually develop staff to reach their potential through evaluation and monitoring of theirdevelopment plan.
- Continually assess opportunities for process improvements and develop and monitor process changeimplementation.
- Proactively participate in the selection and recruitment of suitable and qualified staff.
- Develop supporting staff skills, encourage growth and provide regular performance feedback.
- Assist with training for other departments as Clinical Operations representation, as necessary.
Role Requirements
- To perform this job successfully, an individual must be able to perform each essential duty
- satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to performthe essential functions
- Bachelor’s Degree or local equivalent and/or appropriate experience from the Medical/science background and/or related discipline
- US/LATAM/CAN: a minimum of 6 years of relevant clinical research industry experience
- EU/APAC: In depth proven clinical research industry experience
- Ability to manage all aspects of submissions (start-up and ongoing), and study start-up activities asapplicable for all assigned countries
- Effective prioritization skills and ability to multi-task with meticulous attention to detail
- Ability to liaise successfully with all levels of management at ICON, vendors and clients
- Thorough knowledge of regulatory and EC submission requirements in relevant countries within theiroversight
- Thorough knowledge of ICH, ISO, GCP and other relevant regulations for the conduct of clinical trialsrelated to pharmaceuticals, biologics, medical devices, and combination products
- Strong people management and excellent communication skills with demonstratedcoaching/mentoring skills
- Highly developed problem solving skills
- Ability to facilitate team building, conflict resolution and negotiation as needed to promote productivityand the meeting of timelines
- Competent computer skills
- Fluency in written and spoken English; additional language skills desirable (if applicable)
- Due to the nature of this position it may be required for the employee to travel. Therefore, dependenton the employees location, the employee may be required to possess a valid Drivers license
Benefits of Working in ICON
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
What’s Next
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
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